{"schema_version":"secwatch.filing_event.v1","accession":"0001378325-25-000031","form_type":"8-K","ticker":"CV","cik":"0001378325","company_name":"CapsoVision, Inc","filed_at":"2025-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.261699+00:00","generated_at":"2026-05-16T22:18:44.205037+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"CapsoVision files FDA Breakthrough Device application for pancreatic cancer screening capsule","bullets":["Submitted BDD application to FDA on Nov 6, 2025 for CapsoCam UGI capsule to detect early-stage pancreatic ductal adenocarcinoma.","If granted, the designation would enable accelerated development and closer FDA collaboration on clinical studies.","CapsoCam UGI is a non-invasive, pill-shaped camera with panoramic imaging to visualize duodenal papilla changes.","Pancreatic cancer has 8-10% five-year survival rate; no non-invasive screening exists for the general population."],"urls":{"canonical":"https://secwatch.observer/filing/0001378325-25-000031","json":"https://secwatch.observer/filing/0001378325-25-000031.json","markdown":"https://secwatch.observer/filing/0001378325-25-000031.md","text":"https://secwatch.observer/filing/0001378325-25-000031.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/0001378325-25-000031-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/cv-20251110.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T22:18:44.205037+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}